Company
United StatesPontis Orthopaedics, LLC, San Francisco, CA – FDA Inspections
Inspection records and compliance data for Pontis Orthopaedics, LLC in San Francisco, California. 2 FDA inspections on record, 1 Form 483, last inspected July 05, 2018.
Company Profile
This profile covers Pontis Orthopaedics, LLC based in San Francisco, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 22, 2014. Last inspected July 5, 2018.
Most cited issue areas
- Availability1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 5, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1058009 |
| August 22, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 891110 |
FDA documents
Form 483s (2)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pontis Orthopaedics, LLC
FEI Number
3010034074
Address
2299 Post St Ste 207, San Francisco, California 94115, United States
Country
United States
ID: 5991f036-2715-4626-a7da-503817f9a8af